News from AGA

Henry T. Lynch, MD, came from a humble background, growing up in a rough neighborhood in New York City. He enlisted in the Navy and served in the South Pacific during World War II. Afterward, Dr. Lynch focused his efforts on completing his education, which eventually lead him to the medical field.

After obtaining his high-school equivalency, and completing his undergraduate degree at the University of Oklahoma and his master’s degree in clinical psychology at the University of Denver, his path turned toward the field in which he would make his thrilling and unprecedented discoveries. He studied for a PhD in human genetics at the University of Texas at Austin and received his medical degree from the University of Texas Medical Branch in Galveston. He completed his internship at St. Mary’s Hospital in Evansville, Indiana, and his residency in internal medicine at the University of Nebraska College of Medicine. His first faculty appointment was at The University of Texas MD Anderson Cancer Center.

In 1967, he accepted a position at Creighton, in Omaha, Neb., where he would spend the rest of his storied career. Dr. Lynch was a professor at Creighton University School of Medicine, and the founder and director of the Hereditary Cancer Center at Creighton, established in 1984. He served as chair of the institution’s Department of Preventive Medicine and Public Health, and was named the inaugural holder of the Charles F. and Mary C. Heider Endowed Chair in Cancer Research at Creighton.

A patient he encountered in 1962 – an alcoholic that drank because he believed he would die of colon cancer since everyone in his family had – was the catalyst for his groundbreaking work into the possibility of a hereditary component to some forms of cancer. During this time, it was understood that carcinogenic chemicals and viruses were the primary cause of cancer.

Dr. Lynch provided the first complete description of hereditary nonpolyposis colorectal cancer, a form of colon cancer eventually renamed Lynch syndrome. He continued his research, eventually identifying a hereditary form of breast and ovarian cancers, melanoma, and prostate and pancreatic cancers. His efforts also resulted in one of the world’s largest databases of family cancer histories.

Dr. Lynch passed away on June 2, 2019, at the age of 91. AGA members are sharing their stories and the impact Dr. Lynch had on their work in the AGA Community.

ginews@gastro.org

Lucas Franki contributed to this report.

Henry T. Lynch, MD, came from a humble background, growing up in a rough neighborhood in New York City. He enlisted in the Navy and served in the South Pacific during World War II. Afterward, Dr. Lynch focused his efforts on completing his education, which eventually lead him to the medical field.

After obtaining his high-school equivalency, and completing his undergraduate degree at the University of Oklahoma and his master’s degree in clinical psychology at the University of Denver, his path turned toward the field in which he would make his thrilling and unprecedented discoveries. He studied for a PhD in human genetics at the University of Texas at Austin and received his medical degree from the University of Texas Medical Branch in Galveston. He completed his internship at St. Mary’s Hospital in Evansville, Indiana, and his residency in internal medicine at the University of Nebraska College of Medicine. His first faculty appointment was at The University of Texas MD Anderson Cancer Center.

In 1967, he accepted a position at Creighton, in Omaha, Neb., where he would spend the rest of his storied career. Dr. Lynch was a professor at Creighton University School of Medicine, and the founder and director of the Hereditary Cancer Center at Creighton, established in 1984. He served as chair of the institution’s Department of Preventive Medicine and Public Health, and was named the inaugural holder of the Charles F. and Mary C. Heider Endowed Chair in Cancer Research at Creighton.

A patient he encountered in 1962 – an alcoholic that drank because he believed he would die of colon cancer since everyone in his family had – was the catalyst for his groundbreaking work into the possibility of a hereditary component to some forms of cancer. During this time, it was understood that carcinogenic chemicals and viruses were the primary cause of cancer.

Dr. Lynch provided the first complete description of hereditary nonpolyposis colorectal cancer, a form of colon cancer eventually renamed Lynch syndrome. He continued his research, eventually identifying a hereditary form of breast and ovarian cancers, melanoma, and prostate and pancreatic cancers. His efforts also resulted in one of the world’s largest databases of family cancer histories.

Dr. Lynch passed away on June 2, 2019, at the age of 91. AGA members are sharing their stories and the impact Dr. Lynch had on their work in the AGA Community.

ginews@gastro.org

Lucas Franki contributed to this report.

Henry T. Lynch, MD, came from a humble background, growing up in a rough neighborhood in New York City. He enlisted in the Navy and served in the South Pacific during World War II. Afterward, Dr. Lynch focused his efforts on completing his education, which eventually lead him to the medical field.

After obtaining his high-school equivalency, and completing his undergraduate degree at the University of Oklahoma and his master’s degree in clinical psychology at the University of Denver, his path turned toward the field in which he would make his thrilling and unprecedented discoveries. He studied for a PhD in human genetics at the University of Texas at Austin and received his medical degree from the University of Texas Medical Branch in Galveston. He completed his internship at St. Mary’s Hospital in Evansville, Indiana, and his residency in internal medicine at the University of Nebraska College of Medicine. His first faculty appointment was at The University of Texas MD Anderson Cancer Center.

In 1967, he accepted a position at Creighton, in Omaha, Neb., where he would spend the rest of his storied career. Dr. Lynch was a professor at Creighton University School of Medicine, and the founder and director of the Hereditary Cancer Center at Creighton, established in 1984. He served as chair of the institution’s Department of Preventive Medicine and Public Health, and was named the inaugural holder of the Charles F. and Mary C. Heider Endowed Chair in Cancer Research at Creighton.

A patient he encountered in 1962 – an alcoholic that drank because he believed he would die of colon cancer since everyone in his family had – was the catalyst for his groundbreaking work into the possibility of a hereditary component to some forms of cancer. During this time, it was understood that carcinogenic chemicals and viruses were the primary cause of cancer.

Dr. Lynch provided the first complete description of hereditary nonpolyposis colorectal cancer, a form of colon cancer eventually renamed Lynch syndrome. He continued his research, eventually identifying a hereditary form of breast and ovarian cancers, melanoma, and prostate and pancreatic cancers. His efforts also resulted in one of the world’s largest databases of family cancer histories.

Dr. Lynch passed away on June 2, 2019, at the age of 91. AGA members are sharing their stories and the impact Dr. Lynch had on their work in the AGA Community.

ginews@gastro.org

Lucas Franki contributed to this report.

Physicians with difficult patient scenarios bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, Infliximab and liver abscess
(http://ow.ly/MehK30p2UZr)

2. Positive Cologuard testing in patient on blood thinners
(http://ow.ly/lJXF30p2V12)

3. Recombinant zoster vaccine in IBD patients on biologics
(http://ow.ly/FWGA30p2V1F)

4. Hair loss and Crohn’s disease
(http://ow.ly/C6Sa30p2V2h)

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, Infliximab and liver abscess
(http://ow.ly/MehK30p2UZr)

2. Positive Cologuard testing in patient on blood thinners
(http://ow.ly/lJXF30p2V12)

3. Recombinant zoster vaccine in IBD patients on biologics
(http://ow.ly/FWGA30p2V1F)

4. Hair loss and Crohn’s disease
(http://ow.ly/C6Sa30p2V2h)

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, Infliximab and liver abscess
(http://ow.ly/MehK30p2UZr)

2. Positive Cologuard testing in patient on blood thinners
(http://ow.ly/lJXF30p2V12)

3. Recombinant zoster vaccine in IBD patients on biologics
(http://ow.ly/FWGA30p2V1F)

4. Hair loss and Crohn’s disease
(http://ow.ly/C6Sa30p2V2h)

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

What if all you had to do to ensure that the AGA Research Foundation can have an impact for years to come is to write a simple sentence? Sound impossible?

The AGA Research Foundation provides a key source of funding at a critical juncture in young investigators’ career. Securing the future of the talented investigators we serve really is as simple as one sentence. By including a gift to the AGA Research Foundation in your will, you can support our mission tomorrow without giving away any of your assets today.

Including the AGA Research Foundation in your will is a popular gift to give because it is:

•  Affordable. The actual giving of your gift occurs after your lifetime, so your current income is not affected.
•  Flexible. Until your will goes into effect, you are free to alter your plans or change your mind.
•  Versatile. You can give a specific item, a set amount of money or a percentage of your estate. You can also make your gift contingent upon certain events.

We hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust. It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

Join others in donating to the AGA Research Foundation and help fill the funding gap and protect the next generation of investigators.

Please contact us for more information at foundation@gastro.org or visit http://gastro.planmylegacy.org/.
 

What if all you had to do to ensure that the AGA Research Foundation can have an impact for years to come is to write a simple sentence? Sound impossible?

The AGA Research Foundation provides a key source of funding at a critical juncture in young investigators’ career. Securing the future of the talented investigators we serve really is as simple as one sentence. By including a gift to the AGA Research Foundation in your will, you can support our mission tomorrow without giving away any of your assets today.

Including the AGA Research Foundation in your will is a popular gift to give because it is:

•  Affordable. The actual giving of your gift occurs after your lifetime, so your current income is not affected.
•  Flexible. Until your will goes into effect, you are free to alter your plans or change your mind.
•  Versatile. You can give a specific item, a set amount of money or a percentage of your estate. You can also make your gift contingent upon certain events.

We hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust. It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

Join others in donating to the AGA Research Foundation and help fill the funding gap and protect the next generation of investigators.

Please contact us for more information at foundation@gastro.org or visit http://gastro.planmylegacy.org/.
 

What if all you had to do to ensure that the AGA Research Foundation can have an impact for years to come is to write a simple sentence? Sound impossible?

The AGA Research Foundation provides a key source of funding at a critical juncture in young investigators’ career. Securing the future of the talented investigators we serve really is as simple as one sentence. By including a gift to the AGA Research Foundation in your will, you can support our mission tomorrow without giving away any of your assets today.

Including the AGA Research Foundation in your will is a popular gift to give because it is:

•  Affordable. The actual giving of your gift occurs after your lifetime, so your current income is not affected.
•  Flexible. Until your will goes into effect, you are free to alter your plans or change your mind.
•  Versatile. You can give a specific item, a set amount of money or a percentage of your estate. You can also make your gift contingent upon certain events.

We hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust. It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

Join others in donating to the AGA Research Foundation and help fill the funding gap and protect the next generation of investigators.

Please contact us for more information at foundation@gastro.org or visit http://gastro.planmylegacy.org/.
 

AGA member Zobair Younossi, MD, MPH, and three other expert and patient panelists called upon Congress to help educate policymakers and the public on the increasing burden of NASH and to take steps to prevent its increase, including more funding for research.

Dr. Younossi provided congressional staffers with an informative presentation on the prevalence, adverse clinical outcomes, and economic outcomes of nonalcoholic steatohepatitis (NASH). He noted that 6.65 million adults have NASH – 688,000 have advanced NASH. Treatment of these patients carries an economic burden of $222.6 billion in direct costs and $95.4 billion in lifetime direct costs of advanced NASH.

Although NASH was discovered almost 40 years ago, the prevalence has doubled in the last 15 years and challenges to optimize disease diagnosis and management remain. The briefing was sponsored by the Global Liver Institute and its founder and CEO, Donna Cryer, JD, is a NASH patient and liver transplant recipient. Dr. Younossi noted that, between 2015 and 2030, the percentage of nonalcoholic fatty liver disease (NAFLD) that is related to NASH is projected to increase from 20% to 27%.

AGA thanks Dr. Younossi, the other panelists, and the Global Liver Institute for assembling this important educational forum and encouraging Congress to take action.
 

ginews@gastro.org

AGA member Zobair Younossi, MD, MPH, and three other expert and patient panelists called upon Congress to help educate policymakers and the public on the increasing burden of NASH and to take steps to prevent its increase, including more funding for research.

Dr. Younossi provided congressional staffers with an informative presentation on the prevalence, adverse clinical outcomes, and economic outcomes of nonalcoholic steatohepatitis (NASH). He noted that 6.65 million adults have NASH – 688,000 have advanced NASH. Treatment of these patients carries an economic burden of $222.6 billion in direct costs and $95.4 billion in lifetime direct costs of advanced NASH.

Although NASH was discovered almost 40 years ago, the prevalence has doubled in the last 15 years and challenges to optimize disease diagnosis and management remain. The briefing was sponsored by the Global Liver Institute and its founder and CEO, Donna Cryer, JD, is a NASH patient and liver transplant recipient. Dr. Younossi noted that, between 2015 and 2030, the percentage of nonalcoholic fatty liver disease (NAFLD) that is related to NASH is projected to increase from 20% to 27%.

AGA thanks Dr. Younossi, the other panelists, and the Global Liver Institute for assembling this important educational forum and encouraging Congress to take action.
 

ginews@gastro.org

AGA member Zobair Younossi, MD, MPH, and three other expert and patient panelists called upon Congress to help educate policymakers and the public on the increasing burden of NASH and to take steps to prevent its increase, including more funding for research.

Dr. Younossi provided congressional staffers with an informative presentation on the prevalence, adverse clinical outcomes, and economic outcomes of nonalcoholic steatohepatitis (NASH). He noted that 6.65 million adults have NASH – 688,000 have advanced NASH. Treatment of these patients carries an economic burden of $222.6 billion in direct costs and $95.4 billion in lifetime direct costs of advanced NASH.

Although NASH was discovered almost 40 years ago, the prevalence has doubled in the last 15 years and challenges to optimize disease diagnosis and management remain. The briefing was sponsored by the Global Liver Institute and its founder and CEO, Donna Cryer, JD, is a NASH patient and liver transplant recipient. Dr. Younossi noted that, between 2015 and 2030, the percentage of nonalcoholic fatty liver disease (NAFLD) that is related to NASH is projected to increase from 20% to 27%.

AGA thanks Dr. Younossi, the other panelists, and the Global Liver Institute for assembling this important educational forum and encouraging Congress to take action.
 

ginews@gastro.org

The AGA journals – Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) – are pleased to announce their 2019-2020 editorial fellows.


Gastroenterology
Feng Su, MD
University of Washington, Seattle
@FengSu_MD

Victoria Weis, PhD
Wake Forest School of Medicine, Winston-Salem, N.C.

CGH
Austin Chiang, MD, MPH
Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia
@AustinChiangMD

Jennifer Kolb, MD
University of Colorado Anschutz Medical Campus, Aurora

CMGH
Cambrian Liu, PhD
The Saban Research Institute, Children’s Hospital Los Angeles

Tirthadipa Pradhan-Sundd, PhD
University of Pittsburgh, Pennsylvania
@Tirthadipa

The editorial fellows will be mentored on their respective journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals. The newly expanded program builds on the success of the previous 2 years when Gastroenterology had an editorial fellow.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

ginews@gastro.org

The AGA journals – Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) – are pleased to announce their 2019-2020 editorial fellows.


Gastroenterology
Feng Su, MD
University of Washington, Seattle
@FengSu_MD

Victoria Weis, PhD
Wake Forest School of Medicine, Winston-Salem, N.C.

CGH
Austin Chiang, MD, MPH
Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia
@AustinChiangMD

Jennifer Kolb, MD
University of Colorado Anschutz Medical Campus, Aurora

CMGH
Cambrian Liu, PhD
The Saban Research Institute, Children’s Hospital Los Angeles

Tirthadipa Pradhan-Sundd, PhD
University of Pittsburgh, Pennsylvania
@Tirthadipa

The editorial fellows will be mentored on their respective journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals. The newly expanded program builds on the success of the previous 2 years when Gastroenterology had an editorial fellow.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

ginews@gastro.org

The AGA journals – Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) – are pleased to announce their 2019-2020 editorial fellows.


Gastroenterology
Feng Su, MD
University of Washington, Seattle
@FengSu_MD

Victoria Weis, PhD
Wake Forest School of Medicine, Winston-Salem, N.C.

CGH
Austin Chiang, MD, MPH
Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia
@AustinChiangMD

Jennifer Kolb, MD
University of Colorado Anschutz Medical Campus, Aurora

CMGH
Cambrian Liu, PhD
The Saban Research Institute, Children’s Hospital Los Angeles

Tirthadipa Pradhan-Sundd, PhD
University of Pittsburgh, Pennsylvania
@Tirthadipa

The editorial fellows will be mentored on their respective journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals. The newly expanded program builds on the success of the previous 2 years when Gastroenterology had an editorial fellow.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

ginews@gastro.org

AGA’s microbiome leaders recently met with representatives from FDA’s Center for Biologics Evaluation and Research (CBER) to share clinician and researcher perspectives on fecal microbiota transplantation (FMT) and understand CBER’s current thinking on the regulation of FMT for the treatment of Clostridioides difficile (C. difficile) infection. Here are the key takeaways from AGA’s discussion with CBER.

AGA made clear to FDA the needs and concerns of the clinical and research communities regarding FMT. AGA communicated clinician concerns about patient access to whole-stool FMT being restricted or perhaps eliminated once drugs containing live microbials are FDA approved. AGA’s representatives also shared concerns about the narrow inclusion criteria for current clinical trials and whether the new drugs will be as effective as whole-stool FMT for vulnerable populations such as the elderly or immunocompromised, who make up the majority of patients with C. difficile infection but are often excluded from current trials. Finally, AGA emphasized the need to encourage innovation in product development and the importance of performing controlled safety and efficacy studies on products that can be manufactured predictably and reproducibly.

All stakeholders agreed that the AGA FMT National Registry is an important effort to collect short- and long-term data on the safety and efficacy of FMT. AGA will maintain dialogue with CBER regarding data from the registry and lessons learned. Clinicians practicing FMT are strongly encouraged to participate in the FMT National Registry, which will follow short- and long-term outcomes of patients receiving FMT for up to 10 years. The registry is funded by a grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (award number R24 AI118629) and is a partnership of AGA, the Crohn’s &nd Colitis Foundation, the Infectious Diseases Society of America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

CBER is currently working on an update to the enforcement discretion policy on the use of FMT for C. difficile infection not responsive to standard therapies.Agency representatives noted that all comments will be considered as the agency finalizes the guidance. The current enforcement discretion policy has been in place since July 2013 and was most recently updated by CBER in a draft guidance in March 2016. The policy enables clinicians to use FMT for the treatment of C. difficile infection not responsive to standard therapies without having an investigational new drug (IND) application in place.

Human stool will continue to be regulated as a drug and biological product. The agency stated that human stool does not meet the definition of a tissue and FDA does not intend to change how it is currently classified.

CBER is interested in hearing ideas for novel trial designs that may help address the challenges of patient recruitment for clinical trials in C. difficile infection and other indications for FMT. AGA encourages members to share their thoughts on this topic through the AGA Community.

Following AGA’s meeting with CBER, FDA issued a safety alert because of the death of a patient who died from an FMT containing a multi-drug resistant organism. The agency has since issued additional requirements for IND holders on stool donor screening. AGA will continue to engage with FDA on this issue and share updates as they become available with all members.

Meeting participants from AGA membership included:

• Gail A. Hecht, MD, MS, AGAF, immediate past chair, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Colleen R. Kelly, MD, co-chair, AGA FMT National Registry Steering Committee

• Alexander Khoruts, MD, member, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Gary D. Wu, MD, AGAF, basic research councilor, AGA Institute Governing Board, and member, AGA FMT National Registry Steering Committee


Meeting participants from FDA/CBER included:

• Peter Marks, MD, PhD, Director, CBER

• Celia Witten, PhD, MD, Deputy Director, CBER

• Diane Maloney, JD, Associate Director for Policy, CBER

• Julie Tierney, JD, Senior Policy Advisor for Strategic Planning & Legislation, CBER

• Marion Gruber, PhD, Director, Office of Vaccines Research and Review (OVRR), CBER

• Theresa Finn, PhD, Associate Director for Policy, OVRR, CBER

• Doran Fink, MD, PhD, Deputy Director, Clinical, Division of Vaccines and Related Products Applications, OVRR, CBER

• Paul Carlson, PhD, Senior Staff Fellow, OVRR

• Lorrie McNeill, Director, Office of Communication, Outreach and Development, CBER


This meeting took place on May 6, 2019, at the FDA headquarters in Silver Spring, Md.
 

ginews@gastro.org

AGA’s microbiome leaders recently met with representatives from FDA’s Center for Biologics Evaluation and Research (CBER) to share clinician and researcher perspectives on fecal microbiota transplantation (FMT) and understand CBER’s current thinking on the regulation of FMT for the treatment of Clostridioides difficile (C. difficile) infection. Here are the key takeaways from AGA’s discussion with CBER.

AGA made clear to FDA the needs and concerns of the clinical and research communities regarding FMT. AGA communicated clinician concerns about patient access to whole-stool FMT being restricted or perhaps eliminated once drugs containing live microbials are FDA approved. AGA’s representatives also shared concerns about the narrow inclusion criteria for current clinical trials and whether the new drugs will be as effective as whole-stool FMT for vulnerable populations such as the elderly or immunocompromised, who make up the majority of patients with C. difficile infection but are often excluded from current trials. Finally, AGA emphasized the need to encourage innovation in product development and the importance of performing controlled safety and efficacy studies on products that can be manufactured predictably and reproducibly.

All stakeholders agreed that the AGA FMT National Registry is an important effort to collect short- and long-term data on the safety and efficacy of FMT. AGA will maintain dialogue with CBER regarding data from the registry and lessons learned. Clinicians practicing FMT are strongly encouraged to participate in the FMT National Registry, which will follow short- and long-term outcomes of patients receiving FMT for up to 10 years. The registry is funded by a grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (award number R24 AI118629) and is a partnership of AGA, the Crohn’s &nd Colitis Foundation, the Infectious Diseases Society of America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

CBER is currently working on an update to the enforcement discretion policy on the use of FMT for C. difficile infection not responsive to standard therapies.Agency representatives noted that all comments will be considered as the agency finalizes the guidance. The current enforcement discretion policy has been in place since July 2013 and was most recently updated by CBER in a draft guidance in March 2016. The policy enables clinicians to use FMT for the treatment of C. difficile infection not responsive to standard therapies without having an investigational new drug (IND) application in place.

Human stool will continue to be regulated as a drug and biological product. The agency stated that human stool does not meet the definition of a tissue and FDA does not intend to change how it is currently classified.

CBER is interested in hearing ideas for novel trial designs that may help address the challenges of patient recruitment for clinical trials in C. difficile infection and other indications for FMT. AGA encourages members to share their thoughts on this topic through the AGA Community.

Following AGA’s meeting with CBER, FDA issued a safety alert because of the death of a patient who died from an FMT containing a multi-drug resistant organism. The agency has since issued additional requirements for IND holders on stool donor screening. AGA will continue to engage with FDA on this issue and share updates as they become available with all members.

Meeting participants from AGA membership included:

• Gail A. Hecht, MD, MS, AGAF, immediate past chair, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Colleen R. Kelly, MD, co-chair, AGA FMT National Registry Steering Committee

• Alexander Khoruts, MD, member, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Gary D. Wu, MD, AGAF, basic research councilor, AGA Institute Governing Board, and member, AGA FMT National Registry Steering Committee


Meeting participants from FDA/CBER included:

• Peter Marks, MD, PhD, Director, CBER

• Celia Witten, PhD, MD, Deputy Director, CBER

• Diane Maloney, JD, Associate Director for Policy, CBER

• Julie Tierney, JD, Senior Policy Advisor for Strategic Planning & Legislation, CBER

• Marion Gruber, PhD, Director, Office of Vaccines Research and Review (OVRR), CBER

• Theresa Finn, PhD, Associate Director for Policy, OVRR, CBER

• Doran Fink, MD, PhD, Deputy Director, Clinical, Division of Vaccines and Related Products Applications, OVRR, CBER

• Paul Carlson, PhD, Senior Staff Fellow, OVRR

• Lorrie McNeill, Director, Office of Communication, Outreach and Development, CBER


This meeting took place on May 6, 2019, at the FDA headquarters in Silver Spring, Md.
 

ginews@gastro.org

AGA’s microbiome leaders recently met with representatives from FDA’s Center for Biologics Evaluation and Research (CBER) to share clinician and researcher perspectives on fecal microbiota transplantation (FMT) and understand CBER’s current thinking on the regulation of FMT for the treatment of Clostridioides difficile (C. difficile) infection. Here are the key takeaways from AGA’s discussion with CBER.

AGA made clear to FDA the needs and concerns of the clinical and research communities regarding FMT. AGA communicated clinician concerns about patient access to whole-stool FMT being restricted or perhaps eliminated once drugs containing live microbials are FDA approved. AGA’s representatives also shared concerns about the narrow inclusion criteria for current clinical trials and whether the new drugs will be as effective as whole-stool FMT for vulnerable populations such as the elderly or immunocompromised, who make up the majority of patients with C. difficile infection but are often excluded from current trials. Finally, AGA emphasized the need to encourage innovation in product development and the importance of performing controlled safety and efficacy studies on products that can be manufactured predictably and reproducibly.

All stakeholders agreed that the AGA FMT National Registry is an important effort to collect short- and long-term data on the safety and efficacy of FMT. AGA will maintain dialogue with CBER regarding data from the registry and lessons learned. Clinicians practicing FMT are strongly encouraged to participate in the FMT National Registry, which will follow short- and long-term outcomes of patients receiving FMT for up to 10 years. The registry is funded by a grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (award number R24 AI118629) and is a partnership of AGA, the Crohn’s &nd Colitis Foundation, the Infectious Diseases Society of America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

CBER is currently working on an update to the enforcement discretion policy on the use of FMT for C. difficile infection not responsive to standard therapies.Agency representatives noted that all comments will be considered as the agency finalizes the guidance. The current enforcement discretion policy has been in place since July 2013 and was most recently updated by CBER in a draft guidance in March 2016. The policy enables clinicians to use FMT for the treatment of C. difficile infection not responsive to standard therapies without having an investigational new drug (IND) application in place.

Human stool will continue to be regulated as a drug and biological product. The agency stated that human stool does not meet the definition of a tissue and FDA does not intend to change how it is currently classified.

CBER is interested in hearing ideas for novel trial designs that may help address the challenges of patient recruitment for clinical trials in C. difficile infection and other indications for FMT. AGA encourages members to share their thoughts on this topic through the AGA Community.

Following AGA’s meeting with CBER, FDA issued a safety alert because of the death of a patient who died from an FMT containing a multi-drug resistant organism. The agency has since issued additional requirements for IND holders on stool donor screening. AGA will continue to engage with FDA on this issue and share updates as they become available with all members.

Meeting participants from AGA membership included:

• Gail A. Hecht, MD, MS, AGAF, immediate past chair, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Colleen R. Kelly, MD, co-chair, AGA FMT National Registry Steering Committee

• Alexander Khoruts, MD, member, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Gary D. Wu, MD, AGAF, basic research councilor, AGA Institute Governing Board, and member, AGA FMT National Registry Steering Committee


Meeting participants from FDA/CBER included:

• Peter Marks, MD, PhD, Director, CBER

• Celia Witten, PhD, MD, Deputy Director, CBER

• Diane Maloney, JD, Associate Director for Policy, CBER

• Julie Tierney, JD, Senior Policy Advisor for Strategic Planning & Legislation, CBER

• Marion Gruber, PhD, Director, Office of Vaccines Research and Review (OVRR), CBER

• Theresa Finn, PhD, Associate Director for Policy, OVRR, CBER

• Doran Fink, MD, PhD, Deputy Director, Clinical, Division of Vaccines and Related Products Applications, OVRR, CBER

• Paul Carlson, PhD, Senior Staff Fellow, OVRR

• Lorrie McNeill, Director, Office of Communication, Outreach and Development, CBER


This meeting took place on May 6, 2019, at the FDA headquarters in Silver Spring, Md.
 

ginews@gastro.org

The AGA Research Foundation’s career development awards are invaluable tools for early career investigators to advance their careers in gastroenterology and hepatology research. When Ashish Nimgaonkar, MD, MTech, MS, received the AGA-Boston Scientific Career Development Technology and Innovation Award in 2014, he was able to step up his research and develop a new technological approach for managing patients with chronic liver disease-related complications. We are delighted to introduce you to the work of Dr. Nimgaonkar, medical director in the Johns Hopkins Center for Bioengineering Innovation and Design, department of biomedical engineering, and an assistant professor of medicine and business at Johns Hopkins University.

ginews@gastro.org

Help AGA build a community of investigators through the AGA Research Foundation.

Your donation to the AGA Research Foundation can fund future success stories by keeping young scientists working to advance our understanding of digestive diseases. Donate today at www.gastro.org/donateonline.

The AGA Research Foundation’s career development awards are invaluable tools for early career investigators to advance their careers in gastroenterology and hepatology research. When Ashish Nimgaonkar, MD, MTech, MS, received the AGA-Boston Scientific Career Development Technology and Innovation Award in 2014, he was able to step up his research and develop a new technological approach for managing patients with chronic liver disease-related complications. We are delighted to introduce you to the work of Dr. Nimgaonkar, medical director in the Johns Hopkins Center for Bioengineering Innovation and Design, department of biomedical engineering, and an assistant professor of medicine and business at Johns Hopkins University.

ginews@gastro.org

Help AGA build a community of investigators through the AGA Research Foundation.

Your donation to the AGA Research Foundation can fund future success stories by keeping young scientists working to advance our understanding of digestive diseases. Donate today at www.gastro.org/donateonline.

The AGA Research Foundation’s career development awards are invaluable tools for early career investigators to advance their careers in gastroenterology and hepatology research. When Ashish Nimgaonkar, MD, MTech, MS, received the AGA-Boston Scientific Career Development Technology and Innovation Award in 2014, he was able to step up his research and develop a new technological approach for managing patients with chronic liver disease-related complications. We are delighted to introduce you to the work of Dr. Nimgaonkar, medical director in the Johns Hopkins Center for Bioengineering Innovation and Design, department of biomedical engineering, and an assistant professor of medicine and business at Johns Hopkins University.

ginews@gastro.org

Help AGA build a community of investigators through the AGA Research Foundation.

Your donation to the AGA Research Foundation can fund future success stories by keeping young scientists working to advance our understanding of digestive diseases. Donate today at www.gastro.org/donateonline.

The House of Representatives passed two bills aimed at speeding up the development of generics and biosimilars while the Trump administration finalized a rule to require drug companies to list the price of their products in their television ads.

The House passed two bills to address drug pricing. The House passed H.R. 1503, the Orange Book Transparency Act of 2019, legislation that would make changes to the FDA’s “orange” book to provide better information on brand drug and patent exclusivity. The orange book is used by doctors and pharmacists for information on generic drug approvals and availability. It is also used by generic drug manufacturers to make decisions on where to invest in research and development as it provides information on the exclusivity period for brand name drugs. Similarly, the House passed H.R. 1520, the Purple Book Continuity Act, legislation that would update FDA’s “purple” book on patents and exclusivity for biologics. These are the first bills of the 116th Congress to pass that address the costs of drugs.

The Administration finalizes rule on drug costs in advertising. The Trump administration finalized a rule that would require drug manufacturers to disclose prices on their products in television advertisements. Manufacturers must list a product’s monthly wholesale price or the cost of a typical treatment if it is greater than $35 for 30 days. The information must appear in text large enough for people to read it and should also include a statement that people with insurance may pay a different amount for the product. The rule takes effect in 60 days and the drug industry opposes the rule, which they say could sway patients away from certain medications and lead to more misinformation on the actual costs.

House Appropriations Committee approves $2 billion NIH increase. The House Appropriations Committee approved their fiscal year 2020 Labor, HHS, and Education Appropriations bill that includes a $2 billion increase in NIH funding. The Committee also includes critical report language on several GI research areas including inflammatory bowel disease, colorectal cancer screenings, early onset colorectal cancer, and the role of food as medicine in treating diseases. The bill also includes important language directing CMS to require Medicare Advantage plans to exclude from prior authorization requirements those services that align with evidence-based guidelines and have a high prior authorization approval rate. The language also calls for more transparency for MA plans with prior authorization so physicians are aware of what services require it.

Medical Nutrition Equity Act introduced in House. Rep. Jim McGovern, D-Mass., introduced H.R. 2501, the Medical Nutrition Equity Act, legislation that would mandate coverage of medically necessary foods for individuals with digestive and inherited metabolic disorders. AGA is supportive of this legislation that is critical for patients with digestive diseases and ensures their access to these lifesaving products.
 

ginews@gastro.org

The House of Representatives passed two bills aimed at speeding up the development of generics and biosimilars while the Trump administration finalized a rule to require drug companies to list the price of their products in their television ads.

The House passed two bills to address drug pricing. The House passed H.R. 1503, the Orange Book Transparency Act of 2019, legislation that would make changes to the FDA’s “orange” book to provide better information on brand drug and patent exclusivity. The orange book is used by doctors and pharmacists for information on generic drug approvals and availability. It is also used by generic drug manufacturers to make decisions on where to invest in research and development as it provides information on the exclusivity period for brand name drugs. Similarly, the House passed H.R. 1520, the Purple Book Continuity Act, legislation that would update FDA’s “purple” book on patents and exclusivity for biologics. These are the first bills of the 116th Congress to pass that address the costs of drugs.

The Administration finalizes rule on drug costs in advertising. The Trump administration finalized a rule that would require drug manufacturers to disclose prices on their products in television advertisements. Manufacturers must list a product’s monthly wholesale price or the cost of a typical treatment if it is greater than $35 for 30 days. The information must appear in text large enough for people to read it and should also include a statement that people with insurance may pay a different amount for the product. The rule takes effect in 60 days and the drug industry opposes the rule, which they say could sway patients away from certain medications and lead to more misinformation on the actual costs.

House Appropriations Committee approves $2 billion NIH increase. The House Appropriations Committee approved their fiscal year 2020 Labor, HHS, and Education Appropriations bill that includes a $2 billion increase in NIH funding. The Committee also includes critical report language on several GI research areas including inflammatory bowel disease, colorectal cancer screenings, early onset colorectal cancer, and the role of food as medicine in treating diseases. The bill also includes important language directing CMS to require Medicare Advantage plans to exclude from prior authorization requirements those services that align with evidence-based guidelines and have a high prior authorization approval rate. The language also calls for more transparency for MA plans with prior authorization so physicians are aware of what services require it.

Medical Nutrition Equity Act introduced in House. Rep. Jim McGovern, D-Mass., introduced H.R. 2501, the Medical Nutrition Equity Act, legislation that would mandate coverage of medically necessary foods for individuals with digestive and inherited metabolic disorders. AGA is supportive of this legislation that is critical for patients with digestive diseases and ensures their access to these lifesaving products.
 

ginews@gastro.org

The House of Representatives passed two bills aimed at speeding up the development of generics and biosimilars while the Trump administration finalized a rule to require drug companies to list the price of their products in their television ads.

The House passed two bills to address drug pricing. The House passed H.R. 1503, the Orange Book Transparency Act of 2019, legislation that would make changes to the FDA’s “orange” book to provide better information on brand drug and patent exclusivity. The orange book is used by doctors and pharmacists for information on generic drug approvals and availability. It is also used by generic drug manufacturers to make decisions on where to invest in research and development as it provides information on the exclusivity period for brand name drugs. Similarly, the House passed H.R. 1520, the Purple Book Continuity Act, legislation that would update FDA’s “purple” book on patents and exclusivity for biologics. These are the first bills of the 116th Congress to pass that address the costs of drugs.

The Administration finalizes rule on drug costs in advertising. The Trump administration finalized a rule that would require drug manufacturers to disclose prices on their products in television advertisements. Manufacturers must list a product’s monthly wholesale price or the cost of a typical treatment if it is greater than $35 for 30 days. The information must appear in text large enough for people to read it and should also include a statement that people with insurance may pay a different amount for the product. The rule takes effect in 60 days and the drug industry opposes the rule, which they say could sway patients away from certain medications and lead to more misinformation on the actual costs.

House Appropriations Committee approves $2 billion NIH increase. The House Appropriations Committee approved their fiscal year 2020 Labor, HHS, and Education Appropriations bill that includes a $2 billion increase in NIH funding. The Committee also includes critical report language on several GI research areas including inflammatory bowel disease, colorectal cancer screenings, early onset colorectal cancer, and the role of food as medicine in treating diseases. The bill also includes important language directing CMS to require Medicare Advantage plans to exclude from prior authorization requirements those services that align with evidence-based guidelines and have a high prior authorization approval rate. The language also calls for more transparency for MA plans with prior authorization so physicians are aware of what services require it.

Medical Nutrition Equity Act introduced in House. Rep. Jim McGovern, D-Mass., introduced H.R. 2501, the Medical Nutrition Equity Act, legislation that would mandate coverage of medically necessary foods for individuals with digestive and inherited metabolic disorders. AGA is supportive of this legislation that is critical for patients with digestive diseases and ensures their access to these lifesaving products.
 

ginews@gastro.org

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, infliximab and liver abscess (http://ow.ly/mTod50uyXCQ)

A 22-year-old Crohn’s patient presented to the hospital in septic shock with acute renal failure due to pyogenic liver abscess, which had ruptured into the peritoneal cavity. Member seeks consult from the AGA Community on treatment options given this serious infection.

2. EUS-guided cholecystoenterostomy with LAMS (http://ow.ly/IqLP50uyXLg)

A member poses the question: how long should the stent stay in?

3. Colorectal cancer surveillance in Crohn’s colitis and small duct PSC (http://ow.ly/tbe650uyXQh)

A member asks if you would continue yearly CRC surveillance on a patient with Crohn’s colitis with very limited colonic involvement in the ascending colon, who is currently in clinical remission. The patient also has small duct PSC with early cirrhosis.

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, infliximab and liver abscess (http://ow.ly/mTod50uyXCQ)

A 22-year-old Crohn’s patient presented to the hospital in septic shock with acute renal failure due to pyogenic liver abscess, which had ruptured into the peritoneal cavity. Member seeks consult from the AGA Community on treatment options given this serious infection.

2. EUS-guided cholecystoenterostomy with LAMS (http://ow.ly/IqLP50uyXLg)

A member poses the question: how long should the stent stay in?

3. Colorectal cancer surveillance in Crohn’s colitis and small duct PSC (http://ow.ly/tbe650uyXQh)

A member asks if you would continue yearly CRC surveillance on a patient with Crohn’s colitis with very limited colonic involvement in the ascending colon, who is currently in clinical remission. The patient also has small duct PSC with early cirrhosis.

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, infliximab and liver abscess (http://ow.ly/mTod50uyXCQ)

A 22-year-old Crohn’s patient presented to the hospital in septic shock with acute renal failure due to pyogenic liver abscess, which had ruptured into the peritoneal cavity. Member seeks consult from the AGA Community on treatment options given this serious infection.

2. EUS-guided cholecystoenterostomy with LAMS (http://ow.ly/IqLP50uyXLg)

A member poses the question: how long should the stent stay in?

3. Colorectal cancer surveillance in Crohn’s colitis and small duct PSC (http://ow.ly/tbe650uyXQh)

A member asks if you would continue yearly CRC surveillance on a patient with Crohn’s colitis with very limited colonic involvement in the ascending colon, who is currently in clinical remission. The patient also has small duct PSC with early cirrhosis.

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Perianal fistula found in UC patient (http://ow.ly/S8bJ30okWuO)

A 20-year-old male patient with no previous medical history was seen and treated last year for pancolitis. His physician solicits drug therapy preferences from the GI community, given the age of the patient and a newly discovered perianal fistula.

2. IBD patient with risk of cancer (http://ow.ly/KoGz30oHdjG)

A 62-year-old female patient with a long history of Crohn’s disease developed acute hepatitis. She had a colectomy in 2011 where a one-stage ileo rectal anastomosis was performed instead of a J-pouch. She was in remission under surveillance and mesalamine, until recently. She also has primary sclerosing cholangitis (PSC) and multifocal dysplasia, a combination that raised concern among the GI community about the patient’s risk of cancer.

3. Significant daily pain in Crohn’s patient (http://ow.ly/FHUI30oHdI8)

A recent colonoscopy for a 39-year-old man with Crohn’s disease revealed active disease in the ileum and sigmoid colon with narrowing at the recto-sigmoid colon. The MRE revealed active inflammation at the ileo-colonic anastomosis and of the sigmoid and descending colon, with no noted fistulas. His physician solicits advice in the forum on next steps for the patient, who was experiencing significant pain daily, despite being on a low residue diet and consistent drug therapy.

Other popular clinical discussions:

• WATS imaging in Barrett’s esophagus (http://ow.ly/PrJ330oHdCN)

Members share their opinions and experiences with Wide-Area Transepithelial Sampling (WATS) in Barrett’s esophagus (BE) after mention of recent data demonstrating its promising potential for surveillance in BE patients, despite not yet being approved by the FDA.



• Positive FIT with negative colonoscopy (http://ow.ly/zSxC30oHcZM)

A physician solicits advice on next steps in managing average-risk patients with a positive FIT and negative colonoscopy screening, and asks colleagues if their actions would change after discovering a patient also had non-bleeding hemorrhoids on exam.

More clinical cases and discussions are at https://community.gastro.org/discussions.


 

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Perianal fistula found in UC patient (http://ow.ly/S8bJ30okWuO)

A 20-year-old male patient with no previous medical history was seen and treated last year for pancolitis. His physician solicits drug therapy preferences from the GI community, given the age of the patient and a newly discovered perianal fistula.

2. IBD patient with risk of cancer (http://ow.ly/KoGz30oHdjG)

A 62-year-old female patient with a long history of Crohn’s disease developed acute hepatitis. She had a colectomy in 2011 where a one-stage ileo rectal anastomosis was performed instead of a J-pouch. She was in remission under surveillance and mesalamine, until recently. She also has primary sclerosing cholangitis (PSC) and multifocal dysplasia, a combination that raised concern among the GI community about the patient’s risk of cancer.

3. Significant daily pain in Crohn’s patient (http://ow.ly/FHUI30oHdI8)

A recent colonoscopy for a 39-year-old man with Crohn’s disease revealed active disease in the ileum and sigmoid colon with narrowing at the recto-sigmoid colon. The MRE revealed active inflammation at the ileo-colonic anastomosis and of the sigmoid and descending colon, with no noted fistulas. His physician solicits advice in the forum on next steps for the patient, who was experiencing significant pain daily, despite being on a low residue diet and consistent drug therapy.

Other popular clinical discussions:

• WATS imaging in Barrett’s esophagus (http://ow.ly/PrJ330oHdCN)

Members share their opinions and experiences with Wide-Area Transepithelial Sampling (WATS) in Barrett’s esophagus (BE) after mention of recent data demonstrating its promising potential for surveillance in BE patients, despite not yet being approved by the FDA.



• Positive FIT with negative colonoscopy (http://ow.ly/zSxC30oHcZM)

A physician solicits advice on next steps in managing average-risk patients with a positive FIT and negative colonoscopy screening, and asks colleagues if their actions would change after discovering a patient also had non-bleeding hemorrhoids on exam.

More clinical cases and discussions are at https://community.gastro.org/discussions.


 

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Perianal fistula found in UC patient (http://ow.ly/S8bJ30okWuO)

A 20-year-old male patient with no previous medical history was seen and treated last year for pancolitis. His physician solicits drug therapy preferences from the GI community, given the age of the patient and a newly discovered perianal fistula.

2. IBD patient with risk of cancer (http://ow.ly/KoGz30oHdjG)

A 62-year-old female patient with a long history of Crohn’s disease developed acute hepatitis. She had a colectomy in 2011 where a one-stage ileo rectal anastomosis was performed instead of a J-pouch. She was in remission under surveillance and mesalamine, until recently. She also has primary sclerosing cholangitis (PSC) and multifocal dysplasia, a combination that raised concern among the GI community about the patient’s risk of cancer.

3. Significant daily pain in Crohn’s patient (http://ow.ly/FHUI30oHdI8)

A recent colonoscopy for a 39-year-old man with Crohn’s disease revealed active disease in the ileum and sigmoid colon with narrowing at the recto-sigmoid colon. The MRE revealed active inflammation at the ileo-colonic anastomosis and of the sigmoid and descending colon, with no noted fistulas. His physician solicits advice in the forum on next steps for the patient, who was experiencing significant pain daily, despite being on a low residue diet and consistent drug therapy.

Other popular clinical discussions:

• WATS imaging in Barrett’s esophagus (http://ow.ly/PrJ330oHdCN)

Members share their opinions and experiences with Wide-Area Transepithelial Sampling (WATS) in Barrett’s esophagus (BE) after mention of recent data demonstrating its promising potential for surveillance in BE patients, despite not yet being approved by the FDA.



• Positive FIT with negative colonoscopy (http://ow.ly/zSxC30oHcZM)

A physician solicits advice on next steps in managing average-risk patients with a positive FIT and negative colonoscopy screening, and asks colleagues if their actions would change after discovering a patient also had non-bleeding hemorrhoids on exam.

More clinical cases and discussions are at https://community.gastro.org/discussions.